Current partner codePEPTIDESDE
NCT06864026·Phase 4·INTERVENTIONAL

A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Status

Recruiting

Phase

Phase 4

Enrollment

200

Locations

55

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Interventions

Treatment arms and agents.

DRUG

Tirzepatide

Administered SC

Timeline

From registration to results.

  1. First posted

    Mar 7, 2025

  2. Study start

    Mar 6, 2025

  3. Primary completion

    Nov 2027

  4. Study completion

    Nov 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 11, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy

Time frame · 12 Months

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.

Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy

Time frame · 12 Months

Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.

Secondary outcomes

Percentage of Participants Achieving Tender Joint Count (TJC) ≤1

Time frame · Month 6 and Month 12

Percentage of participants achieving TJC ≤1.

Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1

Time frame · Month 6 and Month 12

Percentage of participants achieving SJC ≤1.

Percentage of Participants Achieving Body Surface Area (BSA) ≤3%

Time frame · Month 6 and Month 12

Percentage of participants achieving BSA ≤3%.

Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2

Time frame · Month 6 and Month 12

The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.

Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15

Time frame · Month 6 and Month 12

The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."

Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2

Time frame · Month 6 and Month 12

The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."

Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss

Time frame · Month 6 and Month 12

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.

Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline

Time frame · Month 6 and Month 12

FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).

Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)

Time frame · Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.

Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID

Time frame · Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA. * Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). * Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide. * Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening). Exclusion Criteria: * Have currently received ixekizumab for more than 4 months or less than 2 months. * Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide). * Are currently enrolled in any other clinical study. * Have a known hypersensitivity to any component of tirzepatide. * Have a personal or family history of medullary thyroid cancer. * Have multiple endocrine neoplasia type 2. * Have type 1 diabetes mellitus. * Have a history of chronic or acute pancreatitis at any time before screening. * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment. * Have a history of ketoacidosis or hyperosmolar state/coma. * Have a history of severe hypoglycemia unawareness within the 6 months before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Study locations

55 registered sites.

Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

Phoenix, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

Sun City, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

Tucson, Arizona, United States

Medvin Clinical Research - Apple Valley

Apple Valley, California, United States

Medvin Clinical Research - Covina

Covina, California, United States

Newport Huntington Medical Group

Huntington Beach, California, United States

Purushotham & Akther Kotha MD, Inc

La Mesa, California, United States

Medvin Clinical Research - Riverside

Riverside, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

Providence Saint John's Medical Foundation

Santa Monica, California, United States

Medvin Clinical Research - Temecula

Temecula, California, United States

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Medvin Clinical Research - Whittier

Whittier, California, United States

Vida Clinical Research

Kissimmee, Florida, United States

Life Clinical Trials

Margate, Florida, United States

CZ Rheumatology

Miami Beach, Florida, United States

Vitalia Medical Research

Palm Beach Gardens, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.